SUPPLY CHAIN ARTICLES
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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How Can We Move RNA Forward In Our Therapeutics Arsenal?
RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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The Cell-Free Revolution: Breaking The Plasmid DNA Bottleneck
I was excited to be given the opportunity to sit down with Jodi Barrientos, CEO, Ribbon Bio, to learn more about the current state of the synthetic DNA space. In the following Q&A, Barrientos and I discuss some of the synthetic DNA industry’s biggest goals and the challenges that stand in the way of bringing synthetic plasmids more commonly into the mRNA development paradigm.
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A "Hot Take" on Personalized mRNA Medicines
mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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The RNA Therapeutics Supply Chain: A Platform of Relationships
Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The single guide RNA (sgRNA) is one of the key components of successful CRISPR gene editing. Here we cover all the important aspects of sgRNA and Synthego’s sgRNA products.
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Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
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Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.
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Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
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Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
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Learn how optimized RNA polymerases enhance mRNA therapeutic quality and transcript integrity by increasing yield and capping efficiency while reducing double-stranded RNA impurities.